Medical Device Recalls

This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.

Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.

38,428 total recalls
0 this month

Showing 24441–24460 of 38,428 recalls

April 12, 2017· Zimmer Biomet, Inc.

Recalled Item: Bone Dowell Harvest Tubes

The Issue: Mislabeling

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 12, 2017· Savaria Concord Lifts, Inc.

Recalled Item: Savaria SL-1000 Stairlift

The Issue: The electrical controller, combined with motor, causes feedback,

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 12, 2017· XTANT MEDICAL INC

Recalled Item: 5.5mm Diameter x 500mm CoCr Straight Rod

The Issue: The material type on the label may incorrectly

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 12, 2017· Savaria Concord Lifts, Inc.

Recalled Item: The Savaria Stairfriend is a Residential

The Issue: Savaria Concord Lifts has decided to initiate a

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 12, 2017· Savaria Concord Lifts, Inc.

Recalled Item: Omega Incline Platform Lift

The Issue: Savaria Concord Lifts Inc has decided to initiate

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 11, 2017· Medica Corporation

Recalled Item: EasyCAL HbA1c Calibrator

The Issue: Patient results determined using this calibrator lot might

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 11, 2017· Sorin Group Italia SRL - CRF

Recalled Item: OVATIO Models: VR 6250

The Issue: Sorin is notifying physicians that certain defibrillators' battery

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 11, 2017· Sorin Group Italia SRL - CRF

Recalled Item: INTENSIA Models: VR 124

The Issue: Sorin is notifying physicians that certain defibrillators' battery

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 11, 2017· Biomet Microfixation, LLC

Recalled Item: Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600

The Issue: Part of the number on the tray lid

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 11, 2017· Sorin Group Italia SRL - CRF

Recalled Item: PARADYM Models: VR 8250

The Issue: Sorin is notifying physicians that certain defibrillators' battery

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 10, 2017· bioMerieux, Inc.

Recalled Item: eMAG System

The Issue: Some anomalies have been identified during manufacturing controls

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 10, 2017· Roche Diagnostics Corporation

Recalled Item: Elecsys PreciControl Varia 3

The Issue: e-barcode and value sheet for PreciControl Varia contains

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 10, 2017· B Braun Medical Inc

Recalled Item: CytoGuard Closed Luer Connector

The Issue: B. Braun is voluntarily recalling 13 lots of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 10, 2017· Ion Beam Applications S.A.

Recalled Item: Proton therapy system -Proteus 235 aka Proteus Plus. A medical

The Issue: A PBS (Pencil Beam Scanning) irradiation may pause

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 10, 2017· Siemens Healthcare Diagnostics Inc

Recalled Item: RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional

The Issue: Patient Demographic Error with Blank Patient ID

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 10, 2017· CooperSurgical, Inc.

Recalled Item: CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit

The Issue: The current secondary packaging, a box, incorrectly states

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 7, 2017· Exactech, Inc.

Recalled Item: Exactech Optetrak Logic CC 15mm Tibial Augment Screws

The Issue: Missing Screw in carton. Nine (9) serial numbers

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 6, 2017· Merge Healthcare, Inc.

Recalled Item: Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite

The Issue: Merge is conducting a hardware recall (replacement) of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 6, 2017· Amendia, Inc

Recalled Item: 01.4mm x 457mm (18in) K-Wire

The Issue: Mislabeling

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 5, 2017· Siemens Healthcare Diagnostics, Inc

Recalled Item: ADVIA Centaur Systems Insulin ReadyPack

The Issue: Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated